Job Description: Director of Site QualityLocation: Ilfracombe, United KingdomIn this role, you will have the opportunity to:Represent the Ilfracombe site as the Quality Management Representative and lead management reviews.Lead and develop the QA site function.Implement the Quality Management System (QMS).Ensure that QMS procedures, work instructions, and IT systems effectively support the Ilfracombe site organization.Collaborate with Global QMS Subject Matter Experts (SME) as required.Support the Global QMS team on global process and procedure changes and represent the site's needs during change management and continuous improvement discussions.Set and monitor Quality Key Performance Indicators (KPIs), including reporting on performance and trend insights within business reviews.Establish effective communication with stakeholders and create cross-functional operating mechanisms to ensure quality goals are met.Essential Requirements:Minimum of a Bachelor's degree, preferably in a Science or Engineering discipline.At least 10 years of experience in Quality Assurance, Quality Engineering, or Product Engineering within Life Science, Medical Device, or Biopharma manufacturing environments.2-4 years of supervisory experience.Knowledge of ISO, FDA, cGMPs, and CFR requirements.Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.Knowledge of quality statistical methods and tools.Experience supporting validation and technology transfer activities.If you are passionate about quality management and have the expertise and experience to excel in this role, we encourage you to apply and join our team in Ilfracombe. Together, we can achieve excellence in quality and continuous improvement!
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